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FDA 510(k)

SIGN HIP CONSTRUCT (SHC), MODEL: 701

K-Number: K083582 · 2009-08-26

ApplicantSurgical Implant Generation Network (Sign)
Decision Date2009-08-26
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGN HIP CONSTRUCT (SHC), MODEL: 701 is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Implant Generation Network (Sign). It received FDA 510(k) clearance on 2009-08-26 under 510(k) number K083582. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGN HIP CONSTRUCT (SHC), MODEL: 701?

SIGN HIP CONSTRUCT (SHC), MODEL: 701 is a medical device that received FDA 510(k) clearance on 2009-08-26. The listed applicant is Surgical Implant Generation Network (Sign). The 510(k) number is K083582.

When did SIGN HIP CONSTRUCT (SHC), MODEL: 701 receive FDA 510(k) clearance?

SIGN HIP CONSTRUCT (SHC), MODEL: 701 received FDA 510(k) clearance on 2009-08-26, under 510(k) number K083582.

Who is the listed applicant for SIGN HIP CONSTRUCT (SHC), MODEL: 701?

The FDA 510(k) record lists Surgical Implant Generation Network (Sign) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGN HIP CONSTRUCT (SHC), MODEL: 701?

The FDA product code for SIGN HIP CONSTRUCT (SHC), MODEL: 701 is KTT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Surgical Implant Generation Network (Sign) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K043200SIGN FIN NAILK022632SIGN IM NAILK013132SIGN IM NAIL

Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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